Multiple Sclerosis Research Australia has welcomed the recent Pharmaceutical Benefits Advisory Committee (PBAC) recommendations for two new oral multiple sclerosis medications.
On Friday, the PBAC recommended that Aubagio (teriflunomide) and Tecfidera (dimethyl fumarate) be listed on the Pharmaceutical Benefits Scheme (PBS) for use in relapsing remitting MS.
The recommendations, if approved by the Federal Government, will provide new affordable treatment options for many people living with MS. As people with MS respond differently to treatments and side-effect profiles differ, a wider range of treatment choices is a welcome development.
Affordable access to new treatments that can better manage the disease are of crucial importance to people with MS and to the Australian community. MS Research Australia welcomes new treatments that have undergone rigorous clinical testing as a way of giving people living with MS more options in reducing the impact of the disease on their lives.
Sativex, an oral spray treatment for spasticity, was also considered at the July meeting of the PBAC, however, it has not been recommended for listing on the (PBS) at this stage. Novartis, the sponsors of Sativex in Australia, stated that they are disappointed with the decision but remain committed to ensuring MS patients can access Sativex for spasticity.
Process for approval of new medications:
The Therapeutic Goods Administration (TGA) is responsible for evaluating the efficacy and safety of new medications.
The PBAC is responsible for recommending whether new TGA approved drugs should be listed for reimbursement on the PBS. The PBAC is required to consider a number of factors when making recommendations, including the clinical efficacy and cost-effectiveness of a treatment relative to other medicines and the cost to the government of a new listing. The PBAC recommendations are then considered for final approval by the Federal Government.